Full Press Release Details
Purple Biotech Reports Additional Positive Interim
Results from its Randomized Phase 2 Pancreatic Cancer Study with CM24 Regarding a Potential Predictive Biomarker for Overall Survival
REHOVOT, Israel, June 27, 2024 (GLOBE NEWSWIRE)
- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company
developing first-in-class oncology therapies that overcome tumor immune evasion and drug resistance, today reported additional positive
interim data from its randomized, controlled, open label, multicenter Phase 2 study (NCT 04731467) of CM24, in combination with Bristol
Myers Squibb's immune checkpoint inhibitor nivolumab and standard of care (SoC) chemotherapy, in second-line metastatic pancreatic
ductal adenocarcinoma (PDAC). These results suggest that serum MPO may be a predictive biomarker for survival in the CM24+Nivolumab +
Nal-IRI/5FU/LV arm. The company also announced that it will host a virtual KOL event on Thursday, July 11, 2024 at 10:30 AM ET to discuss
the results in detail. To register for the event, click here.
Interim results that were presented on June 1,
2024 during a late-breaking abstract poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated
a 26% reduction in risk of death (HR=0.74) and a 28% risk reduction in progression or death (HR=0.72) in previously-treated patients treated
with CM24+nivolumab+Nal-IRI/5FU/LV vs. Nal-IRI/5FU/LV chemotherapy alone (i.e., SoC). Median OS was prolonged by 2.1 months and median
PFS was extended by 1.9 months in the CM24+nivolumab+Nal-IRI/5FU/LV regimen vs. SoC. The prolongation of both OS and PFS by the CM-24-nivolumab
therapy is further supported by a higher ORR (25% vs 7%), DCR (63% vs 40%), and decrease in CA19-9 level (61% decrease vs. 34% increase).
"The concordant and consistent improvement
in primary and all secondary endpoints including OS, PFS, ORR, DCR and CA19-9 are compelling, and the addition of a potential predictive
biomarker provides further support for the potential of CM24 in combination with nivolumab plus the SoC chemotherapy regimen Nal-IRI/5FU/LV
to improve clinical outcomes for those with advanced metastatic PDAC." stated Gil Efron, Chief Executive Officer of Purple Biotech.
"We plan to report further clinical study data in the second half of 2024."
New Interim Exploratory Biomarker Data:
This interim biomarker analysis comparing the
experimental and control arms suggests measured baseline serum MPO as a potential clinical outcome biomarker for CM24-nivolumab therapy.
While in a small sample size, these findings suggest
that serum MPO may be a predictive biomarker for the treatment effect of CM24+Nivo+ Nal-IRI/5FU/LV on OS.
Presentation of the biomarker data is planned
at an upcoming medical conference.
The experimental arms of the randomized Phase
2 study administered patients with CM24 plus nivolumab and a choice of one of two SoC chemotherapies used in second-line PDAC, and dependent
on prior first line therapy regimen; either gemcitabine/nab-paclitaxel or liposomal irinotecan (Nal-IRI)/5-fluorouracil (5-FU) and leucovorin
(LV) (Nal-IRI/5FU/LV), while the control arms administered either respective SoC chemotherapy alone. Interim results are provided for
the Nal-IRI/5FU/LV sub study. An analysis of the gemcitabine/nab-paclitaxel sub study will be performed later when the data sufficiently
CM24 is a humanized monoclonal antibody that blocks
CEACAM1, an immune checkpoint protein responsible for tumor immune evasion and poor tumor response and/or resistance to immune checkpoint
inhibitors. Neutrophil extracellular traps (NETs) which are involved in immune evasion and metastasis known to affect disease progression
and patient survival. CM24, a CEACAM1 antibody, was reported1 to also bind to NET structures and significantly suppresses the
NET-induced migration of various cancer cells, as an additional Mechanism of Action. In an earlier part of this study, CM24+nivolumab
treatment significantly reduced the level of the NET marker, as represented by measurable MPO in patient serum.
The poster presentation at ASCO 2024 may be viewed
on Purple Biotech's website HERE and the abstract may be accessed on ASCO's website HERE.
About Purple Biotech
Purple Biotech Ltd. (NASDAQ/TASE: PPBT) is a clinical-stage company
developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance. The Company's oncology pipeline
includes NT219, CM24 and IM1240. NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. A Phase
1 dose escalation study is being concluded and a Phase 2 study of NT219 at its recommended Phase 2 level in combination with cetuximab
in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN) is planned. CM24 is a humanized
monoclonal antibody that blocks CEACAM1, an immune checkpoint protein that supports tumor immune evasion and survival through multiple
pathways. The Company is advancing CM24 as a combination therapy with anti-PD-1 checkpoint inhibitors in a Phase 2 study for the treatment
of pancreatic ductal adenocarcinoma (PDAC). The Company has entered into a clinical collaboration agreement with Bristol Myers Squibb
for the Phase 2 clinical trials to evaluate the combination of CM24 with the PD-1 inhibitor nivolumab in addition to chemotherapy. The
Company is also advancing a preclinical platform of conditionally-activated tri-specific antibodies that engage both T cells and NK cells
to induce a strong, localized immune response within the tumor microenvironment. The cleavable capping technology confines the compound's
therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients.
The third arm of the antibody specifically targets the Tumor Associated Antigen (TAA). The technology presents a novel mechanism of action
by unleashing both innate and adaptive immune systems to induce an optimal anti-tumor immune response. IM1240 is the platform's
lead tribody in development that targets 5T4 expressed in a variety of solid tumors and is correlated with advanced disease, increased
invasiveness and poor clinical outcomes. The Company's corporate headquarters are located in Rehovot, Israel. For more information,
please visit https://purple-biotech.com/.
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"project", "forecast", "continue" or "anticipate" or their negatives or variations of
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place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect
our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve
known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results,
performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by
the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating
to: the plans, strategies and objectives of management for future operations; product development for NT219, CM24 and IM1240; the process
by which such early stage therapeutic candidates could potentially lead to an approved drug product is long and subject to highly significant
risks, particularly with respect to a joint development collaboration; the fact that drug development and commercialization involves a
lengthy and expensive process with uncertain outcomes; final results from clinical studies, including our NT219 and CM24 studies, may
vary from the interim analysis, our ability to successfully develop and commercialize our pharmaceutical products; the expense, length,
progress and results of any clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical
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on Form 20-F for the year ended December 31, 2023 and in our other filings with the U.S. Securities and Exchange Commission ("SEC"),
including our cautionary discussion of risks and uncertainties under "Risk Factors" in our Registration Statements and Annual
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Chief Financial Officer